FDA Registration
Active
🇺🇸 United States
Nemcomed FW LLC
Reg #: 3006128100
·
FEI: 3006128100
·
Expires 2026
Products
111
Proprietary Names
92
Establishment Types
1
Classifications
111
Registration Details
- Registration Name
- Nemcomed FW LLC
- Registration Number
- 3006128100
- FEI Number
- 3006128100
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8727 Clinton Park Drive, 8414 Clinton Park Drive
- City
- FORT WAYNE
- State
- IN
- ZIP
- 46825
- Country
- US
Owner / Operator
- Firm Name
- Avalign Instruments & Implants
- Operator Number
- 9008280
- Address
- 8727 Clinton Park Drive, --
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46825
- Country
- US
- Correspondent
- Jeff Robinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-01-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-09-10 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-17 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2023-04-11 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-11-01 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-11-01 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-01-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-05-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-05-28 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-05-28 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-05-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-05-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-05-28 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-11-28 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-17 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-11-28 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-01-28 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2013-01-28 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2013-01-28 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2026-01-27 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2013-01-21 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2015-09-23 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-11-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-26 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-01-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-17 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2021-12-27 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2021-02-07 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2023-09-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Prosthesis, Ankle, Uncemented, Non-Constrained | NTG | Class 3 | Unknown | No | 2016-01-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2014-01-07 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-04-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2014-01-07 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-01-17 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-01-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2017-04-13 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2017-04-13 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-06-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2026-01-27 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2026-01-26 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-21 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2026-01-27 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-17 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2015-06-01 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2026-01-27 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2026-01-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-31 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2026-01-27 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2013-01-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-17 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2014-01-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-08-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2016-05-23 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2023-09-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-17 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-17 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-17 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2015-06-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2011-07-18 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2023-09-10 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2023-09-10 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2023-09-21 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-01-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-17 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-01-17 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2011-07-18 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-01-17 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2026-01-27 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2015-06-01 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-17 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2026-01-27 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-17 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2013-01-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2017-04-13 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2011-07-18 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2018-11-28 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2017-04-13 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2013-01-21 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2023-09-10 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-21 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-01-17 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2017-04-13 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-01-17 |
Proprietary Names
PEEK Prevail Cervical Interbody
Medtronic IPC Powerease System
234850714 DISTAL SM MEDIAL HUM PLT 14 H
234850712 DISTAL SM MEDIAL HUM PLT 12 H
234850716 DISTAL SM MEDIAL HUM PLT 16 H
Awl
PROX TARGETING GUIDE HUMERAL 225550400
MDN OBLIQUE HOLE ADAPTOR HUM 225550401
PROX TARGETING GDE TIBIAL 225550300
Slap Hammer
FLEXIBLE DRILL SCREW II SHAFT MODULAR
Inbone Combo Wrench 12MM/16MM
Inbone Extraction Wrench
Inbone Combo Wrench 14MM/18MM
Wrench
235852705 RADIAL STYLOID LOCKING PLATE 5H RT
235852703 21DIAL STYLOID LOCKING PLATE 3H RT
235852805 RADIAL STYLOID LOCKING PLATE 5H LT
235852803 RADIAL STYLOID LOCKING PLATE 3H LT
Orthopedic Manual Surgical
ES2 SPINAL SYSTEM
Reliance Lite
AVS ANCHOR-C CERVICAL CAGE SYSTEM
XIA III
ARIA
NEMCOMED ORTHOPEDIC
Prophecy Adapter 16MM Insert
Prophecy Adapter 18MM Insert
Prophecy C-Bracket Adapter
Prophecy Adapter Screw Adjust
SMALL CM FLEX CAPT SET SC 00249003506
STD CM FLEX CAPT SET SCREWDRIVER 00249003507
Vertestack Spinal System
Medtronic Catalyft LS Expandable Interbody System
DePuy 2.4/3.2/4
Rasp 671150940, 671151040 671151140, 789351000, 789351100, 789351200, 789351300, 789351400, 789351500, 789351600
rasp handle
Stimulation instrument
Cannula, Surgical, General & Plastic Surgery
Arthroscopic Instruments
Extractor
OsteoCentric APFT Wires and Drill Sleeves
Mallet
Zimmer Affixus
Medtronic Drills, Burrs, Trephines & Accessories
Alphatec ALIF SA
Medtronic CD Horizon Spinal System
DePuy Expedium Verse Navigation Driver - Shaft
2.5mm modular retaining driver
4mm modular driver, flexible
Silony - T10 Straight Screwdriver, Modular
Medtronic K141599
Flexible Occipital Drill, 6MM
Drill Bit
NuVasive NVJJB System
ZMR Hip System
instrument
Driver, Prosthesis
Pilot Drill
Inbone Drive LH Reamer
Flexible Occipital Tap
Bone Tap
234753500 REG LAT CALCANEAL PLT RT
234753600 REG LAT CALCANEAL PLT LT
301021107 - 301021115
Template
Rasp Alignement Tip Sz 10 thru 20
DePuy Synthes NAV Drill Guide Assembly
Depth Resection Gage
Anatomical Shoulder TM Combined System
Retractor
ROMANELLI RETRACTOR
Patella Reamer Clamp
Trephine
Medtronic Capstone R Spinal System
Bender
Curette
Johnson&Johnson Orthopedic Stereotaxic Instrument
Probe
Handle, Scalpel
Osteotome
Miller Ratchet Injector 506950600
Power-Flo Cement Injector 506950800
Radial Styloid LK Plate 00235852703, 00235852705, 0023585252803, 00235852805
Capstone Control Spinal System
Synthes Synmesh
DePuy Synthes Trialtis Drill Sleeve
Shoulder Innovations - Humeral Short Stem System
Compression Instrument
Surgical Tray
crimper, pin
Instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)